FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1191911
·
Received October 1, 2008
Report
- Report Number
- 1644487-2008-02382
- Event Type
- Malfunction
- Date Received
- October 1, 2008
- Date of Event
- August 1, 2008
- Report Date
- September 2, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUD DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED TO MFR THAT THE PHYSICIAN'S HAND HELD SCREEN FROZE DURING A SYSTEM DIAGNOSTIC TEST AND WOULD NOT MOVE ON TO DISPLAY THE TEST RESULTS. THERE WAS NO TROUBLESHOOTING PERFORMED WHEN THE EVENT OCCURRED. ONE WEEK FOLLOWING THE OCCURRENCE, A HARD RESET WAS PERFORMED AND THE DEVICE CONTINUED FUNCTIONING NORMALLY. THE NON-WORKING HAND HELD AND SOFTWARE HAVE BEEN RETURNED TO MFR AND ANALYSIS IS UNDERWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 521371 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |